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OpenTrials
Completed

NCT Number: NCT01683435

The Value of HBA in the Evaluation of Idiopathic Infertility

We would like to determine if HBA® testing of sperm in couples with presumed idiopathic infertility will reveal lower binding percentages than in couples with an identifiable cause of infertility either male factor or tubal factor

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Continuum Reproductive Center

New York, 10019, United States

About this study

We would like to determine if HBA® testing of sperm in couples with presumed idiopathic infertility will reveal lower binding percentages than in couples with an identifiable cause of infertility either male factor or tubal factor We would like to determine if patients with abnormal HBA binding have decreased IVF outcome: decreases clinical pregnancy rate, implantation rate, and increased miscarriage rate

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • . All groups will include females under 40 years of age undergoing 1st IVF cycle 3 groups
  • Abnormal Semen Analysis (sperm count <10 million/ml and /or rapid progressive motility < 50 %, WHO morphology <30%) normal HSG , normal ovarian reserve testing and ovulation testing
  • Unexplained infertility- normal ovarian reserve testing and ovulation testing (FSH< 10, AMH>1.0) Normal ovulatory cycles, normal WHO semen analysis. Normal tubes on HSG or Laparoscopy
  • Tubal infertility as assessed by HSG or laparoscopy

Exclusion criteria

  • women over 40, prior failed IVF

Treatment and study plan

HBA binding assay

Other

HBA binding assay will be preformed on the discarded portion of semen analysis used for IVF.

Primary outcomes

  1. In each of these groups we will assess presence of HBA bound sperm

    Time frame: immediate at time of preforming HBA test

Sponsors and collaborators

Lead sponsor

St. Luke's-Roosevelt Hospital Center

Other

Registry information

Official study title

The Value of Hyaluronic Binding Assays (HBA) in the Evaluation of Idiopathic Infertility

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 11, 2012
Registry last updated
Sep 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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